Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 58-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,179,062. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose a method for assisting a surgeon. The method comprises providing an orientation device comprising a display and at least one inertial sensor, registering the orientation device at a first location, coupling the orientation device to a surgical instrument, positioning the orientation device and the surgical instrument at a second location after registering the orientation device at the first location, wherein in the second location the prosthetic component is at least partially within an acetabulum of a pelvis of a patient, wherein an angle measurement is presented on the display and aligning the prosthetic component based on on-screen graphics presented on the display of the orientation device.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 58-66, 72, 73, 76, and 77 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2002/0077540 to Kienzle, III et al. in view of U.S. Patent Pub. No. 2005/0251026 to Stone.
As to Claim 58, Kienzle, III discloses a method for assisting a surgeon [0007, 0031-0032]. The method comprises providing an orientation device (191) comprising a display (170, [0045]), coupling the orientation device (191) to a surgical instrument (192, [0047]), recording a first measurement when a selected location on a femur is contacted [0045-0044], orienting a prosthetic cup (190, Fig. 9), and measuring a second measurement [0048] when the selected location on a femur is contacted [0048, 0052].
As to Claim 59, Kienzle, III discloses a method for assisting a surgeon further comprising comparing the first measurement and the second measurement to determine changes in leg length or joint offset [0052].
As to Claim 62, Kienzle, III discloses a method for assisting a surgeon further comprising assessing a pre-operative x-ray (120, [0030-0031]).
As to Claim 63, Kienzle, III discloses a method for assisting a surgeon wherein recording the first measurement comprises recording a position in three-dimensional space relative to a reference frame (development of reference frame in [0045-0046]).
As to Claim 64, Kienzle, III discloses a method for assisting a surgeon further comprising determining an orientation of a plane (development of pelvic coordinate system in [0045-0046]).
As to Claim 65, Kienzle, III discloses a method for assisting a surgeon further comprising inputting goals for adjusting leg length or joint offset (described in [0052]).
As to Claim 72, Kienzle, III discloses a method for assisting a surgeon [0007, 0031-0032]. The method comprises providing an orientation device (191) comprising a display (170, [0045]), wherein the orientation device records a first reference measurement before a prosthetic component is positioned [0045-0044], positioning the prosthetic component (190, Fig. 9), wherein the orientation device compares a second reference measurement after a prosthetic component is positioned with the first reference measurement [0048] and displaying a change in leg length or joint offset on the display of the orientation device [0048, 0052].
As to Claim 73, Kienzle, III discloses a method further comprising analyzing pre-operative x-rays (120) to determine what changes in joint offset and leg length are necessary to bring the hip into symmetry [0030-0031].
As to Claim 76, Kienzle, III discloses a method further comprising aligning the orientation device with an axis of the leg [0046, 0048].
As to Claim 77, Kienzle, III discloses a method further comprising eliminating errors in leg length and joint offset caused by movement of the femur [0051].
As to Claims 58-66, Kienzle, III discloses the claimed invention except for wherein the orientation device includes at least one inertial sensor, wherein the orientation device communicates with another sensor, wherein the selected location is on the greater trochanter, further comprising positioning an additional sensor on the patient.
Stone discloses a method for assisting a surgeon [0009] including an orientation device (10) that includes at least one inertial sensor (32, 34, 36, [0045]). The orientation device (10) communicates with another sensor [0041-0042]. The selected location is on the greater trochanter (418, [0091-0092]). The method includes positioning an additional sensor on the patient [0041-00343] in order to provide the surgeon with accurate angular position information [0045].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method for assisting a surgeon of Kienzle, III with the inertial sensor modification of Stone in order to provide the surgeon with accurate angular position information.
Claims 67-71, 74, 75 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Pub. No. 2002/0077540 to Kienzle, III et al. in view of U.S. Patent Pub. No. 2005/0251026 to Stone in further view of U.S. Patent Pub. No. 2005/0113846 to Carson.
As to Claims 67, Kienzle, III discloses a method for assisting a surgeon [0007, 0031-0032]. The method comprises providing an orientation device (191) comprising a display (170, [0045]), coupling the orientation device (191) to a surgical instrument (192, [0047]), displaying on the display to position a prosthetic cup (190, Fig. 9) in an acetabulum [0055], displaying on the display to assess the landmark after positioning the prosthetic cup [0052, 0059], and displaying on the display changes in leg length or joint offset [0052].
As to Claim 69, Kienzle, III discloses a method further comprising displaying instructions to assess a plan [0048].
As to Claims 59, 60, 62, 63, and 66-77, Kienzle, III discloses the claimed invention except for wherein the orientation device includes at least one inertial sensor, wherein the on-screen graphics comprise orientation data received from the at least one inertial sensor, wherein the at least one inertial sensor provides a measurement relative to gravitational zero.
Stone discloses a method for assisting a surgeon [0009] including an orientation device (10) that includes at least one inertial sensor (32, 34, 36, [0045]). The on-screen graphics (18a, 18b, 18c, Fig. 1) comprise orientation data received from the at least one inertial sensor [0039, 0045]. The at least one inertial sensor provides a measurement relative to gravitational zero [0044, 0075] in order to provide the surgeon with accurate angular position information [0045].
As to Claims 59, 60, 62, 63, and 66-77, Kienzle, III and Stone disclose the claimed invention except for displaying instructions on the display to record a landmark, displaying instructions on the display to position a prosthetic cup, further comprising requesting a user selection, further comprising providing feedback to the user on the orientation of the prosthetic cup, further comprising providing feedback to the user on impacting the prosthetic cup relative to a plane, wherein the display comprises a touchscreen display.
Carson discloses a method for assisting a surgeon [0074-0077] wherein the on-screen graphics comprise instructive images to record a landmark [0112-0113], wherein the on-screen graphics comprise textual instructions [0112], wherein the on-screen graphics comprise an indicator to aid the user in maintaining a particular orientation [0111, 0112], method for assisting a surgeon a user to request a selection [0112-0113]. The orientation device allows a user to enter data [0089]. The method further comprises providing feedback to the user on the orientation of the prosthetic cup [0074] and further comprising providing feedback to the user on impacting the prosthetic cup relative to a plan [0074]. The display comprises a touchscreen display (24, [0100]) in order to provide the surgeon with calculated directions for accurate implantation [0009].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method for assisting a surgeon of Kienzle, III and Stone with the on screen graphics modification of Carson in order to provide the surgeon with calculated directions for accurate implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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